CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,416 enrolled
Drug / intervention
LY2216684 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01173601
NCT01173601Phase 3Completed

A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Fixed-Dose 12 Milligrams (mg) and 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment

Eli Lilly and Company·interventional·Posted Aug 2, 2010·Updated Apr 17, 2018

In Brief

A Phase 3 clinical trial evaluating LY2216684, Placebo, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 1,416 participants across 63 sites in 7 countries.

Detailed Summary

The primary purpose of this study is to assess whether at least 1 dose of LY2216684 (12 milligrams \[mg\] or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, Latvia, Poland, Russia, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2, 2010
Enrollment StartNov 1, 2010
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.9 years ago

Interventions

LY2216684drug

Placebodrug

SSRIdrug

Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study.